FDA 510(k)

Stellar M22

K-Number: K250809 · 2025-04-16

Decision Date2025-04-16

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Stellar M22 is a medical device manufactured by Lumenis Be, Ltd.. It received FDA 510(k) clearance on 2025-04-16 under approval number K250809. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stellar M22?

Stellar M22 is a medical device that received FDA 510(k) clearance on 2025-04-16. It is manufactured by Lumenis Be, Ltd.. The 510(k) number is K250809.

When was Stellar M22 approved by the FDA?

Stellar M22 received FDA 510(k) clearance on 2025-04-16, under approval number K250809.

What company makes Stellar M22?

Stellar M22 is manufactured by Lumenis Be, Ltd..

What is the FDA product code for Stellar M22?

The FDA product code for Stellar M22 is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.